check_circleStudy Completed
Cardiovascular Agents
Bayer Identifier:
14769
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
To establish the bioequivalence between riociguat tablet 0.5 mg intended to be marketed (#501) and riociguat tablet 0.5 mg used for clinical samples (#511) in Japanese healthy adult male subjects.
Trial purpose
The study will be conducted in a single-center, randomized, non-blinded, two-way crossover study in Japanese healthy adult male subjects. 24 subjects will be selected among the subjects undergoing the screening examination conducted within 4 weeks before drug administration of period 1. Single oral doses of riociguat tablet 0.5 mg #501 and riociguat tablet 0.5 mg #511 will be given to selected 24 subjects under the fasting condition with a wash-out interval of 7 days or longer.
One day before the drug administration of each period the subjects will be admitted to the clinical site. During the hospitalization, blood samples for riociguat and its metabolite BAY 60-4552 (M-1) pharmacokinetics will be taken, and the subjects will undergo several tests for safety up to 72 hrs after the administration. Follow up examination will be conducted between Day 7 and Day 10 of period 2.
One day before the drug administration of each period the subjects will be admitted to the clinical site. During the hospitalization, blood samples for riociguat and its metabolite BAY 60-4552 (M-1) pharmacokinetics will be taken, and the subjects will undergo several tests for safety up to 72 hrs after the administration. Follow up examination will be conducted between Day 7 and Day 10 of period 2.
Key Participants Requirements
Sex
MaleAge
20 - 30 YearsTrial summary
Enrollment Goal
24Trial Dates
August 2010 - September 2010Phase
Phase 1Could I Receive a placebo
NoProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Osaka Pharmacology Clinical Research Hospital | Osaka, 532-0003, Japan |
Primary Outcome
- Bioequivalence between two tablet formulations of Riociguat assessed using AUC and C(max) calculated from plasma riociguat concentrationdate_rangeTime Frame:up tp 72 hoursenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2